Research Paper Index

Research Paper no. 11 2008–09

The future of organ donation in Australia: moving beyond the ‘gift of life’

Contents

List of acronyms

Acknowledgements

Thanks to two external readers and Parliamentary Library staff who provided helpful comments on earlier drafts of this Research Paper. The authors remain responsible for any errors or omissions.

Introduction

Despite widespread public support for the concept of organ donation in Australia, the nation has one of the lowest rates of organ donation in the world.  

Without an increase in the rate of organ donation in Australia, Australians suffering from life-threatening illnesses and awaiting an organ donation will continue to die at an ever increasing rate. 

In this context, there is substantial interest in finding ways of translating Australians’ stated commitment to organ donation into improved actual organ donation rates. It was with this goal in mind that a National Clinical Taskforce on Organ and Tissue Donation was established by the Howard Government in October 2006. The Taskforce was to provide the Australian Government with evidence-based advice on ways to improve the rate of safe, effective and ethical organ, eye and tissue donation for transplantation in Australia. In January 2008, the Taskforce submitted its final report, which was intended to serve as the ‘road map’ for reform of the sector with a view to lifting the organ donor rate in the future. This report identified significant systemic problems within the Australian organ donation and transplantation sector, and contained six critical areas for action and 51 separate recommendations for improving Australia’s organ donation and transplantation system. On 2 July 2008, the Rudd Labor Government announced a proposed national reform package intended to ‘establish Australia as a world leader in organ donation for transplantation’.[1] The reform package was endorsed by the Council of Australian Governments on 3 July 2008, and a Bill to implement the measures contained in the package introduced to the Parliament on 18 September 2008.[2] The proposed package follows in all its essentials the recommendations of the Taskforce.

It is likely that implementation of a number of the Taskforce’s recommendations would improve the rate of organ donation and transplantation in Australia, at least in the short- to medium-term. International experience and, closer to home, South Australia’s experience, has shown that a standardised donation process in hospitals, combined with a proactive donor detection program performed by well-trained transplant coordinators, can help to convert many potential donors into actual donors.[3]

However, the Taskforce’s recommended changes are neither likely to meet the existing need for organs, nor to provide for a sustainable supply of organs into the future.

In certain key respects, the Taskforce’s considerations may be viewed as being confined within the terms of a ‘gift of life’ doctrine. This doctrine emphasises that donation is and must be grounded in altruism and egalitarianism. Such a doctrine does not allow for consideration of a number of possible options for improving organ donation systems’ operations and for expanding the amount of organs available for transplantation—options that have been implemented in other countries. To the extent that the Taskforce did not depart from aspects of the ‘gift of life’ doctrine, the range of options proposed by the Taskforce for improving the organ donation system in Australia, and for expanding the number of organs available for transplantation, was delimited. In the terms of its own analogy, it may be argued that the Taskforce provided the government with only a partial ‘road map’ for reform, one that represents only a portion of the territory. Moreover, in as much as the Taskforce’s ‘road map’ does not challenge the principles that are central to the ‘gift of life’ doctrine, it is, arguably, premised on a flawed and unrealistic notion of organ donation, and of human nature.

The paper is divided into two separate parts. The first part is largely descriptive. It examines the organ donation sector in Australia as it currently stands, and the National Clinical Taskforce’s assessment of this sector. The paper then identifies the perceived merits of the Taskforce’s recommendations for change, and the source of the constraint on the Taskforce’s recommendations for reforms.

The second part of the paper explains an alternative basis and approach to organ donation in Australia. It discusses the ‘gift of life’ and problems with this doctrine, before identifying policy options for improving organ donation in Australia that are foreclosed through such a doctrine. Specifically, the paper considers opt-in versus opt-out (or presumed consent) arrangements, questions of transparency and informed consent in donation, the issue of directed and non-directed donation, next-of-kin consent arrangements and the option of payment and incentives for organ donation.

Part 1

Organ donation

Organ donation involves the removal of tissue from one person’s body to allow the transplantation of that tissue into another person’s body. Whole organs such as the heart, lungs, liver, pancreas and kidneys can be donated, as well as sections of tissue such as heart valves, corneas, tendons and skin. Organs and tissue are usually removed from people who have recently died. Indeed, because organs for transplantation need to be removed soon after death, very few people die in a way that enables them to donate organs. However, kidneys and parts of the liver and pancreas may also be removed for transplantation from living donors. The removal of organs and tissue is a surgical procedure that, in Australia, takes place in a hospital operating theatre. Organ transplantation is an effective procedure for those people who are facing the possibility of organ failure, leading to debility or death. 

Organ donation in Australia

The process of donating and transplanting organs in Australia is complex and involves a large number of people and organisations acting in diverse roles. Apart from individual donors and recipients and their families themselves, there is a large organ transplantation sector and many mechanisms in place to allow for transplantation to occur.

The National Clinical Taskforce has identified a number of key stakeholders that make up the organ donation and transplantation sector in Australia. These stakeholders, along with the roles they fulfil, are:

• regulatory bodies, such as the Therapeutic Goods Administration (TGA), are responsible for regulation and licensing, and the National Health and Medical Research Council (NHMRC) provides advice on ethical issues
• professional colleges and societies are involved in developing clinical guidelines and representing health workers. Professional education programs are developed through agencies such as the Australasian Donor Awareness Program (ADAPT)
• eye and tissue banks, which are usually state-based, coordinate the retrieval of eyes, bones, skin, heart valves and musculoskeletal tissue
• state-based organ donation agencies are responsible for promoting and coordinating organ donation within their jurisdictions
• transplant centres within hospitals are specialised locations where transplantation of certain organs can occur
• organ donation-related data collection is primarily undertaken through the Australia and New Zealand Organ Donation Registry (ANZOD). ANZOD draws together information collected through organ-specific registries
• the Australian Organ Donor Register (AODR) and the NSW Roads and Traffic Authority act as registers of consent for the donation of organs following death, and
• community organisations, including peak bodies and foundations, develop awareness campaigns, while other disease-specific groups such as Kidney Health Australia are also involved in promoting organ donation.[4]

Statistics

A wide range of data on organ donation and transplantation in Australia, including rates of donation, characteristics of organ donors and rates and outcomes of organ transplantation, are collected and made available. The following tables present the most recent available data from the Australia and New Zealand Organ Donation Registry (ANZOD) on actual deceased donors along with a summary of actual deceased donor and donors per million population (dpmp) rates by year and by state and territory for the years 1989 to 2007.

These data indicate that the overall number of organ donors in Australia has remained relatively constant over the years, with some variation evident between jurisdictions. The median rate of dpmp for Australia as a whole is 10 dpmp. As indicated above, in terms of dpmp, South Australia has consistently out-performed the other states, with a median rate of 17 dpmp.

There are no accurate figures available on what percentage of those who have died were potential organ donors. Obtaining statistics on the number of potential donors has been identified as a crucial factor in being able to improve actual donation rates as well as to assist in comparing the performance of different methods used to improve rates.[5]  The Australian Organ Donor Register (AODR) states that less than one per cent of all those who die in hospital each year are declared brain dead and are able to donate their organs.[6] However, a 2006 study of potential donors in Victorian hospitals found that it was the practice of some clinicians to not formally diagnose brain death in patients unless family members have consented to organ donation.[7] This study audited deaths in 12 hospitals between 2002 and 2004. Of 17 230 deaths, 106 were actual donors. Of the remainder, 280 were identified by the audit as realistic potential donors and 116 as potential donors with next-of-kin consent.[8] These figures indicate that 1.6 per cent of all hospital deaths in the audited hospitals were realistic potential donors. The study found that there was a next-of-kin consent rate of 53 per cent and, after taking into account the unavoidable loss of 10 of the potential donors with next-of kin-consent, only 38 per cent of potential donors became actual organ donors.[9] Although the number of potential organ donors is not entirely clear, the study of Victorian hospitals and AODR figures indicate that this number is very low, and highlight the importance of maximising the actual donors within this cohort.

The final tables in this section detail the number of Australians on waiting lists for organs by type of organ and jurisdiction as well as over time. Waiting list numbers for organ transplantation have not changed significantly over the past decade. A significant majority of those patients on organ transplant waiting lists are awaiting kidney transplants, with livers and lungs the next most frequent organs in demand. In 2006, the average waiting time for a kidney transplant was 3.79 years from a deceased donor and 1.38 years from a living donor. In the same year, the average waiting time for a liver transplant was 205 days, for a heart transplant, 145 days and for a lung transplant, 187 days. The mean waiting time for a pancreas in 2006 was 1.9 years and for a pancreas islet, 1.4 years.[10]

^a NSW population excludes residents of the Southern Area Health Service (included in ACT population)

Source: Australia and New Zealand Organ Donation Registry (ANZOD), ‘Summary of Organ Donation 2008’: http://www.anzdata.org.au/anzod/Updates/anzodsummary.htm#Donors,
accessed on 12 August 2008.

Waiting lists

Source: Australia and New Zealand Organ Donor Registry, Registry Report 2008, ANZOD, http://www.anzdata.org.au/anzod/ANZODReport/anzodreport.htm#2008, accessed on 26 August 2008.

Sources: Australia and New Zealand Organ Donor Registry, Registry Report 2008, ANZOD, http://www.anzdata.org.au/anzod/ANZODReport/anzodreport.htm#2008 and Registry Report 2002, http://www.anzdata.org.au/anzod/v1/AR-2002.html, accessed on 26 August 2008.

Policy and legislation

Under Australia’s federal legal system, legal regulation of organ donation is the responsibility of the states and territories. Each state and territory has separate legislation covering organ donation and transplantation, including laws governing consent for organ donation. Not only is there no Commonwealth legislation governing organ donation, but there is also no national coordinating body or agency with legislated powers. As a result, legislation and regulation of Australia’s organ donation and transplantation sector, which covers a broad range of activities and procedures, differs across the country. While there is no Commonwealth legislation concerning organ donation, there are some general guidelines and protocols that are applicable to all states. These guidelines and protocols are discussed below.

Consent

State and territory legislative frameworks relating to transplantation are based on the notion of informed consent. Individuals can choose to express consent for their organs to be taken in the event of their death. Where people give their consent for their organs to be used for transplantation purposes, this consent is recorded on a centralised register. This consent takes the form of a legal agreement that their organs can be used, if needed, for transplantation. However, registration of consent is not a legally-binding directive. Under different state and territory legislation, consent can be expressed in a variety of different ways. In NSW and Queensland, for example, donation may only proceed where the deceased has previously given written consent. In Victoria, consent can be given in writing or orally during the last stages of illness of the deceased. In other states and territories, the form that the expression of consent for organ donation must take is not specified.

In cases where no legal consent has been registered, next-of-kin or close family members are able to give consent for organs of the deceased to be donated. Where the deceased person’s next-of-kin cannot be contacted, the states and territories differ with regard to the question of whether or not they allow donation to proceed. In NSW, WA and Tasmania, where no consent was registered by the deceased and a next-of-kin cannot be contacted, donation may not proceed. In Victoria, SA, NT and ACT, where reasonable attempts have been made to contact the next-of-kin and there is no reason to believe that either the family or the deceased would object to the deceased’s organs being donated, then donation can lawfully proceed.[11]

Not all state and territory legislation requires that family members be consulted as to whether or not organ donation should occur. However, in practice, whether or not an individual has expressed their consent for donation, family members are always consulted.[12] Donation will not occur where family members are strongly opposed to such a procedure, even when the deceased person’s consent has been registered.

Definition of death

For the purposes of organ donation and transplantation within a given jurisdiction, it is necessary to have an agreed-upon definition of death. The two most frequently used definitions are brain death and/or cardiac death.

In 1977, an Australian Law Reform Commission (ALRC) report on organ donation and transplantation recommended that a statutory definition of death be introduced into Australian law that could be applied generally, and not only in the context of transplantation.[13] All state and territory legislation that applies to organ donation includes a definition of death, with the exception of SA and WA. South Australia has the separate Death Definition Act 1983 and WA legislation does not explicitly define death. The ALRC report recommended that death be defined as either the ‘irreversible cessation of all function of the brain of the person’ or ‘irreversible cessation of circulation of blood in the body of a person’.[14] Although these definitions leave the determination of detailed criteria to medical professionals (see below), they form the basis of state and territory statutory definitions. The definition used in Queensland’s Transplantation and Anatomy Act 1979 is used only for the purposes of that particular act.

As indicated above, Western Australia is the only state or territory not to include a definition of death in its legislation. However, the section of the WA Human Tissue and Transplant Act 1982 relating to the authority of designated officers, states that tissue or organs shall not be removed from a body for the purposes of transplantation unless two medical practitioners with specific qualifications (that vary from state to state) have declared that the ‘irreversible cessation of all function of the brain of the person has occurred’.[15]

The main pieces of state and territory legislation relating to organ donation and transplantation are the:

• Transplantation and Anatomy Act 1978 (ACT)
• Human Tissue Act 1983 (NSW)
• Human Tissue Transplant Act 1979 (NT)
• Transplantation and Anatomy Act 1979 (QLD)
• Transplantation and Anatomy Act 1983 (SA)
• Human Tissue Act 1985 (Tas)
• Human Tissue Act 1982 (Vic) and the
• Human Tissue and Transplant Act 1982 (WA).

Australian Organ Donor Register

The Australia Organ Donor Register (AODR), which is overseen by Medicare Australia, is now the primary register of consent in Australia. It is a register of consent for donated organs to be used for transplantation purposes alone, and not for scientific or other purposes. The AODR was established in 2000 as a national register of people’s intent to donate. Following a review in 2004–05, the Australian Health Ministers’ Conference (AHMC) decided that the AODR would be changed from a register of intent to a register of consent. The stated aim of this change was ‘to ensure that the known wishes of the deceased, whether consenting or objecting, are respected and followed through’.[16] However, as indicated above and discussed in further detail later in this paper, to register consent is not to make a legally-binding directive. In most states and territories, legislation only makes provisions for the expression of a wish to donate. Therefore, as it stands, the AODR can not meet the stated aims of the AHMC.

It is currently possible to register consent, intent to consent or an objection to donation. Registrations of consent or objection to organ donation are only possible for people who are over the age of 18, through signing the appropriate form. Registrations of intent can be performed online by anyone over the age of 16 with a Medicare number. A registration of an objection to organ donation by the person concerned is recognised by most jurisdictions in Australia, and will override any other decision made by a family member. However, based on anecdotal evidence, the National Clinical Taskforce has reported that, in some jurisdictions, donation can still occur if the next-of-kin have given their consent, despite a registered objection by the deceased.[17]

NSW and SA continue also to operate their own donor registration system through the Roads and Traffic Authority and Transport SA, respectively. Under this system, individuals are able to indicate their consent or objection on their driver’s licence application form (in addition to registration on the AODR). Before the introduction of the AODR, all states collected information on organ donation through the driver’s licence application process. Almost all of the state-collected registration data was transferred to the AODR as registrations of intent. Some concerns have been expressed regarding the quality of these data.[18] Consent registrations transferred to the AODR can be accepted as consent to donate in all jurisdictions except Queensland. SA continues to collect registrations but provides the information to the AODR. NSW does not automatically transfer registrations it collects through the RTA to the AODR.  

Ethical guidelines

Following the changes made to the AODR in 2005, the Australian Health Ministers’ Advisory Council (AHMAC) charged the National Health and Medical Research Council (NHMRC) with undertaking a review of its guidelines, Recommendations for the Donation of Cadaveric Organs and Tissues for Transplantation (1996). This review also considered background papers from the Australian Health Ethics Committee and conducted consultations with relevant groups and stakeholders. The new NHMRC guidelines, Organ and Tissue Donation After Death, For Transplantation, provide a guide to ethical standards relating to organ donation for health professionals. The guidelines are based on the principles that:

• donation of organs and tissues is an act of altruism and human solidarity
• organs and tissues for transplantation should be obtained in ways that:
• demonstrate respect for all aspects of human dignity
• respect the wishes, where known, of the deceased
• give precedence to the needs of the potential donor and the family over the interests of organ procurement
• as far as possible, protect recipients from harm and
• recognise the needs of all those directly involved, including the donor, recipient, families, carers, friends